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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Validity and generalisability of the studies

    • No randomised controlled trials or non-randomised comparative studies were identified.

    • Patients from the US and Europe were included.

    • Most studies used the Cardioband device. One study used the Trialign system, which is no longer available.

    • The studies included the first patients to have the procedure.

    • Most studies only reported 30-day outcomes. The longest mean follow up was 604 days, in a single-arm study of 30 patients (Nickenig, 2021).

    • Four studies included patients who had moderate or worse tricuspid regurgitation and 1 included only those who had severe or worse tricuspid regurgitation (Korber, 2021).